RAQA Data Analyst

Job Description

Primary Function of Position

RAQA Data Analyst will be a member of the Quality Data Analytics (QDA) team and use technical expertise and a solid understanding of quality and regulatory business processes and needs to turn data into insightful information. The data analyst will work closely with various business teams to collect, clarify, and translate business data requirements into data solutions, reports and analytics as required.

The analyst will be heavily involved with the use, distribution, and successful delivery of data and reports on a periodic basis. The successful candidate must excel in a high-energy, focused, small-team environment with profound understanding of Intuitive systems, product profile, company quality management system (QMS) as well as business processes. More importantly, the qualified candidate should have a good understanding of concurrent and legacy systems with extensive knowledge and hands‑on experiences of using a variety of BI tools for dashboards, ability to work independently, communicate effectively with stakeholders, awareness of AI/ML concepts and their applications in data analysis while managing multiple projects in a fast‑paced environment.

Essential Job Duties

• Develop and deliver data solutions to support RAQA business stakeholders such as Audit, Post Market Surveillance, Product Quality/Quality Operations, Regulatory Affairs, Supplier Quality, Quality Systems and Compliance.
• Collaborate with key stakeholders to understand business processes, KPIs, metrics and critical needs for new requests and enhancements.
• Extract and analyze business data from EDW (associates with data from various source systems such as SAP, CRM, Salesforce, Track Wise, Veeva) to meet reporting and analysis requirements.
• Conduct deep dives analysis into data sets including system logs to uncover insights and key data trends. Apply critical thinking and sound judgment in selecting appropriate methods and techniques to solve business problems.
• Design actionable and insightful dashboards to support effective decision making and optimize data analysis processes to automate and standardize reporting.
• Conduct code and application reviews to ensure adherence to best practices, troubleshooting issues as needed.
• Transform query solutions into sustainable self-service reporting tool to drive operational efficiencies.
• Integrate innovative data science approaches to automate processes and deliver impactful, data driven solutions.
• Stay informed about business process changes for dashboard updates and enhancements, provide ongoing support for dashboards and reports, ensuring availability, performance, and reliability.
• Create user documentation for internal team reference, outlining methodology and best practices to ensure consistent processes and knowledge sharing.
• Assist in the development and validation of data analysis reports to meet software verification and validation requirements.
• Ensure compliance with global regulatory standards while protecting intellectual property.
• Conduct ad hoc analysis as needed to support business requirements and provide necessary assistance during audits.
• Demonstrates awareness of AI and Machine Learning concepts and their applications in data analysis.
• Perform additional duties as assigned.